New PARP1 inhibitor targets Hard-to-Treat cancers

NCT ID NCT07695142

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This trial tests an experimental drug called HSK46256, which blocks a protein called PARP1 that helps repair DNA in cancer cells. The study includes adults with advanced solid tumors who have not responded to standard treatments. Researchers aim to find the safest dose and check whether the drug can shrink tumors or slow their growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HSK46256 (a PARP1 inhibitor)
What this could lead to
If successful, this could provide a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early phase 1 trial, so the drug may not prove safe or effective. Side effects and limited benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 275 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years, voluntarily participate and provide signed informed consent, * ECOG performance status 0-1 or KPS \>60; estimated life expectancy ≥12 weeks, * Histologically or cytologically confirmed locally advanced or metastatic solid tumors, failed prior standard therapy, intolerant to standard therapy, or no available standard therapy, * Dose escalation: prior treatment with one line of non-selective PARP inhibitor allowed, * Documented HRR gene mutation, * Agree to provide tumor tissue and/or blood samples, * Fertile participants must agree to use effective contraception during study and for 3 months after last dose; negative pregnancy test for females, Exclusion Criteria: * Other malignancies within past 2 years (except adequately treated basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma); * Uncontrolled moderate to large pleural, pericardial, or peritoneal effusions; * Prior anticancer therapy or concomitant use of CYP3A4 strong/moderate inhibitors/inducers within protocol-specified washout periods; * Prior anticancer treatment toxicity not resolved to CTCAE ≤Grade 1 (except alopecia, skin toxicity); * Any condition affecting drug swallowing or significantly impacting drug absorption/PK; * Severe or uncontrolled cardiac disease (QTcF prolongation, significant arrhythmia, LVEF \<50%, recent MI/heart failure); * Arterial/venous thromboembolic events within 6 months deemed uncontrolled risk; * Severe/uncontrolled diabetes, hypertension, active bleeding, epilepsy, COPD, interstitial lung disease, active systemic infection; * Unstable systemic disease (severe hepatic/renal/metabolic disorders); * Prior MDS or AML diagnosis, or history of hematopoietic stem cell transplantation; * Major surgery or severe trauma within 4 weeks; * HIV positive, active hepatitis B/C, or active syphilis; * Known hypersensitivity to study drug or excipients; * Participation in another interventional trial within 4 weeks; * Pregnant or lactating women;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, China

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